ZIANA- clindamycin phosphate and tretinoin gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

clindamycin phosphate (UNII: EH6D7113I8) (clindamycin - UNII:3U02EL437C), tretinoin (UNII: 5688UTC01R) (tretinoin - UNII:5688UTC01R)

Available from:

Bausch Health US, LLC

INN (International Name):

clindamycin phosphate

Composition:

clindamycin 12 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZIANA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. ZIANA Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. Pregnancy Category C. There are no well-controlled trials in pregnant women treated with ZIANA Gel. ZIANA Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ZIANA Gel was tested for maternal and developmental toxicity in New Zealand White Rabbits with topical doses of 60, 180 and 600 mg/kg/day. ZIANA Gel at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity following dermal administration of ZIANA Gel for 2 weeks prior to artificial insemination and continuing until gestation day 18, inclusive. For purposes of comparisons of the animal expos

Product summary:

ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel is supplied as follows: Storage and Handling

Authorization status:

New Drug Application

Summary of Product characteristics

ZIANA- CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL
BAUSCH HEALTH US, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIANA GEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZIANA GEL.
ZIANA (CLINDAMYCIN PHOSPHATE 1.2% AND TRETINOIN 0.025%) GEL
FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
ZIANA Gel is a lincosamide antibiotic and retinoid combination product
indicated for the topical treatment of acne vulgaris
in patients 12 years or older. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Topical gel: Clindamycin phosphate 1.2% and tretinoin 0.025% gel in 30
and 60 gram tubes. (3)
CONTRAINDICATIONS
ZIANA Gel is contraindicated in patients with regional enteritis,
ulcerative colitis, or history of antibiotic–associated colitis.
(4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Observed local adverse reactions in patients treated with ZIANA Gel
were skin erythema, scaling, itching, burning, and
stinging. Other most commonly reported adverse events (≥1% in
patients treated with ZIANA Gel) were nasopharyngitis,
pharyngolaryngeal pain, dry skin, cough, and sinusitis. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT VALEANT PHARMACEUTICALS
NORTH AMERICA LLC AT 1-800-
321-4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 3/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
®
®
Apply a pea-sized amount to the entire face once daily at bedtime. Do
not apply to eyes, mouth, angles of the nose, or
mucous membranes. (2)
ZIANA Gel is not for oral, ophthalmic, or intravaginal use. (2)
Colitis: Clindamycin can cause severe colitis, which may result in
death. Diarrhea, bloody diarrhea, and colitis
(including pseudomembranous colitis) have been reported with the use
of clindamycin. ZIANA